An interventional study of Family involvement in Critical Illness and Delirium, sponsored by St. Joseph's Healthcare Hamilton. Active, not recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by St. Joseph's Healthcare Hamilton · Not applicable, Interventional, and Treatment
An ICU admission is stressful for not only patients but their families as well. Research has shown that involving family members during a loved one's ICU stay can be helpful for them, but there is not clear direction on the best way to do this. For patients, family presence as well as early movement during their ICU stay has been shown to help recovery from things like delirium (a state of confusion) faster, and might prevent the weakness that can happen with a stay in the ICU. In this study, the investigators will explore whether having family help with moving patients through physiotherapy guided exercise can help both patients and families have a better experience and result from their ICU stay.
The investigators hypothesize that family involvement in activities as part of an overall physiotherapy treatment plan will provide a tangible means for family members to engage in the care of their critically ill loved one, thus improving outcomes for both critically ill patients and family members.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's planned enrollment of 20 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →St. Joseph's Healthcare Hamilton is the lead sponsor of 137 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients to receive mobility interventions from trained family members
Other: Family involvement
Family delivery of mobility activities
Feasibility - consent rate
We define a successful consent rate as \> 70% of SDMs or patients approached to consent, agreeing to take part in the study
Time frame: Study duration - up to one year
Feasibility - recruitment rate
We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial
Time frame: Study duration - up to one year
Feasibility - protocol adherence
We define successful adherence as average family involvement in ≥ 3 sessions/week. Furthermore, adherence to documentation of involvement will be successful if documented by family for ≥80% of sessions
Time frame: During ICU stay, censored at 1 month
Feasibility - resources
Physiotherapist and nurse outcomes will include inability to train families due to physiotherapy or team resources, and number of sessions per week cancelled due to inadequate staffing resources during the patients ICU stay.
Time frame: Study duration - up to one year
Patient Delirium
CAM-ICU
Time frame: During ICU stay, censored at 1 month
Patient & Family PTSD symptoms
IES-R
Time frame: 1 & 3 months
Adverse Events
Falls, hypotension, bradycardia, line removal, unplanned extubation, inappropriate family intervention, unexpected injuries
Time frame: During ICU stay, censored at 1 month
Family satisfaction
23-item Family Satisfaction in the ICU questionnaire; HADS scale
Time frame: 1 & 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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St. Joseph's Healthcare Hamilton